Serlift Adverse Reactions

Side-effects which occurred significantly more frequently with sertraline than placebo in multiple dose studies were: nausea, diarrhea/loose stools, anorexia, dyspepsia, tremor, dizziness, insomnia, somnolence, increased sweating, dry mouth and sexual dysfunction (principally ejaculatory delay in males).
The side-effect profile commonly observed in double-blind, placebo-controlled studies in patients with OCD and PTSD was similar to that observed in patients with depression.
In pediatric OCD patients, side-effects which occurred significantly more frequently with sertraline than placebo were: headache, insomnia, agitation, anorexia, tremor. Most were of mild to moderate severity.
Post-marketing surveillance: Cardiovascular: Blood pressure disturbances including postural hypotension, tachycardia.
Eye disorders: Abnormal vision.
Gastro-intestinal: Vomiting, abdominal pain.
Nervous system: Amnesia, headache, drowsiness, movement disorders, paraesthesia, hypoaesthesia, depressive symptoms, hallucinations, aggressive reaction, agitation, anxiety, psychosis, depersonalisation, nervousness, panic reaction and signs and symptoms associated with serotonin syndrome which include fever, rigidity, confusion, agitation, diaphoresis, tachycardia, hypertension and diarrhea.
There have also been reports of manic reaction, although this phenomenon may be part of the underlying disease.
Convulsions (Seizures): Sertraline should be discontinued in any patient who develops seizures.
Musculoskeletal: Arthralgia, myalgia.
Hepatic/pancreatic: Rarely, pancreatitis and serious liver events (including hepatitis, jaundice and liver failure). Asymptomatic elevations in serum transaminases (SGOT and SGPT) have been reported in association with sertraline administration (0.8, 1.3%), with an increased risk associated with the 200 mg daily dose. The abnormalities usually occurred within the first 1 to 9 weeks of drug treatment and promptly diminished upon drug discontinuation.
Renal & urinary disorders: Urinary retention.
Reproductive: Hyperprolactinemia, galactorrhoea, menstrual irregularities, anorgasmy.
Skin and allergic reactions: Rash (including rare reports of erythema multiforme, photosensitivity), angioedema, ecchymoses, pruritus and anaphylactoid reactions.
Metabolic: Rare cases of hyponatremia have been reported and appeared to be reversible when sertraline was discontinued. Some cases were possibly due to the syndrome of inappropriate antidiuretic hormone secretion. The majority of reports were associated with older patients, and patients taking diuretics or other medications.
Haematologic: There have been rare reports of altered platelet function and/or abnormal clinical laboratory results in patients taking sertraline. While there have been reports of thrombocytopenia, abnormal bleeding or purpura in several patients taking sertraline, it is unclear whether sertraline had a causative role.
General: Malaise.
Other: Withdrawal reactions have been reported with sertraline. Common symptoms include dizziness, paraesthesia, headache, anxiety and nausea. Abrupt discontinuation of treatment with sertraline should be avoided. The majority of symptoms experienced on withdrawal of sertraline are non-serious and self-limiting.
In pediatric clinical trials in depression the following adverse events were reported at a frequency of at least 2% of patients and occurred at a rate of at least twice that of placebo: dry mouth (2.1% vs 0.5%), hyperkinesia (2.6% vs 0.5%), tremor (2.1% vs 0%), diarrhea (9.5% vs 1.6%), vomiting (4.2% vs 1.1%), agitation (6.3% vs 1.1%), anorexia (5.3% vs 1.1%) and urinary incontinence (2.1% vs 0%).
Suicidal thoughts and suicide attempts were mainly observed in clinical trials with Major Depressive Disorder.